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Self Cranial Electrical Stimulation (CES) for Pain in Older Adults With Knee Osteoarthritis (Self CES for Knee Pain)

NCT ID: NCT04016259

Last Updated: 2020-11-16

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-08-01

Study Completion Date

2019-11-21

Brief Summary

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The purpose of this study is to determine the feasibility, safety, and preliminary efficacy of a two-week self Cranial Electrical Stimulation(CES) on pain in older adults with knee osteoarthritis(OA)

Detailed Description

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Conditions

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Osteo Arthritis Knee

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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Self-CES

Group Type EXPERIMENTAL

Cranial Electrical Stimulation (CES)

Intervention Type DEVICE

CES will be applied for 60 minutes per session daily for 2 weeks (Monday to Friday) via the Alpha-Stim M Electromedical Products International, Inc., Mineral Wells, TX).

Sham-CES

Group Type PLACEBO_COMPARATOR

Sham-CES

Intervention Type DEVICE

For sham CES, the electrodes will be identical look and be placed in the same positions as for active stimulation, but the stimulator will not deliver electrical current.

Interventions

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Cranial Electrical Stimulation (CES)

CES will be applied for 60 minutes per session daily for 2 weeks (Monday to Friday) via the Alpha-Stim M Electromedical Products International, Inc., Mineral Wells, TX).

Intervention Type DEVICE

Sham-CES

For sham CES, the electrodes will be identical look and be placed in the same positions as for active stimulation, but the stimulator will not deliver electrical current.

Intervention Type DEVICE

Other Intervention Names

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Alpha-Stim M Alpha-Stim M

Eligibility Criteria

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Inclusion Criteria

* have self-reported unilateral or bilateral knee OA pain, according to American College of Rheumatology criteria
* have had knee OA pain in the past 3 months with an average of at least 30 on a 100 Numeric Rating Scale (NRS) for pain
* can speak and read English
* have a device with internet access that can be used for secure video conferencing for real- time remote supervision
* have no plan to change medication regimens for pain throughout the trial
* are able to travel to the coordinating center
* are willing and able to provide written informed consent prior to enrollment

Exclusion Criteria

* history of brain surgery, brain tumor, seizure,stroke, or intracranial metal implantation
* serious medical illness, such as uncontrolled hypertension (i.e., systolic blood pressure/ diastolic blood pressure ≥ 150/95 mm Hg)heart failure, or history of acute myocardial infarction
* alcohol/substance abuse
* cognitive impairment
* pregnancy or lactation
* hospitalization within the preceding year for psychiatric illness
Minimum Eligible Age

50 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The University of Texas Health Science Center, Houston

OTHER

Sponsor Role lead

Responsible Party

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Hyochol Ahn

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Hyochol Ahn, PhD, RN, MSN

Role: PRINCIPAL_INVESTIGATOR

The University of Texas Health Science Center, Houston

Locations

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The University of Texas Health Science Center at Houston

Houston, Texas, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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HSC-SN-19-0452

Identifier Type: -

Identifier Source: org_study_id